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NCT03997084 Clinical Trial

Patent Foramen Ovale Closure Reduce in SCUBA-divers

Patent Foramen Ovale Clinical Trial

Official title:
Patent Foramen Ovale Closure Reduce in SCUBA-divers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03997084
Other study ID # 2017-01-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date May 1, 2019

Study information
Verified date June 2019
Source Skane University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

It has been proposed that there would not be an increased risk of DCI after closure of the interatrial communication, i.e. patent foramen ovale (PFO).

Recruitment information / eligibility
Status Completed
Enrollment 9
Est. completion date May 1, 2019
Est. primary completion date May 1, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- catheter-based PFO-closure because of DCI

Exclusion Criteria:

-

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• phone interviews
phone interviews

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Skane University Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Dives Interview based on a questionnaire with questions focusing on the dive habits and DCI events. 2017-01-01 until 2019-01-01
See also
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Active, not recruiting NCT04950192 - Philips Intracardiac Echocardiography (ICE) Clinical Registry
Not yet recruiting NCT04549272 - Assessment of Early Vascular Damage With Advanced Neuroimaging in Patient With Patent Foramen Ovale
Completed NCT02621528 - Lifetech CeraFlex™ Post-Market Surveillance Study N/A
Terminated NCT01018355 - The Effect of Device Closure of Patent Foramen Ovale in Elderly Patients With Crytogenic Stoke/TCI N/A
Completed NCT00831259 - Risk of Stroke in Pulmonary Embolism With a Patent Foramen Ovale (PFO) N/A
Not yet recruiting NCT05360771 - Study on the Safety and Effectiveness of the SnowyTM PFO Closure System N/A
Recruiting NCT05546320 - Comparison of the Effect of Medication Therapy in Alleviating Migraine With Patent Foramen Ovale Phase 4
Recruiting NCT05561660 - COMParison of the EffecT of dEvice Closure in Alleviating Migraine With PFO (COMPETE-2) Phase 4
Completed NCT03904277 - Does Patent Foramen Ovale Size Matter in Men and Women
Recruiting NCT06120270 - CeraFlex PFO Closure System PMCF Study
Terminated NCT01773252 - Right to Left Cardiac Shunt Detection Phase 3
Completed NCT01216423 - Pulmonary Embolism and Stroke in Patient With Patent Foramen Ovale N/A
Completed NCT03377465 - Biomarkers, Hemodynamic and Echocardiographic Predictors of Ischemic Strokes and Their Influence on the Course and Prognosis N/A
Active, not recruiting NCT04738071 - International Multicenter Patent foRamen OVale & strokE (IMPROVE) Registry
Not yet recruiting NCT06413147 - Long-term Procedural and Device Related Complications of PFO Closure
Not yet recruiting NCT06344494 - Cardiac Interventional ICE Imaging Trial N/A